Secondary Direct Food Additives Permitted in Food for Human Consumption, 7394-7396 [05-2808]
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7394
Federal Register / Vol. 70, No. 29 / Monday, February 14, 2005 / Rules and Regulations
Frequency: 12 reports to DOT per year
for each respondent.
Estimated Annual Burden Hours: An
estimated 360 hours annually.
F. Unfunded Mandates Reform Act
The Department has determined that
the requirements of Title II of the
Unfunded Mandates Reform Act of 1995
do not apply to this rulemaking.
G. Trade Impact Assessment
The Trade Agreement Act of 1979
prohibits Federal agencies from
engaging in any standards or related
activity that create unnecessary
obstacles to the foreign commerce of the
United States. The statute also requires
consideration of international standards
and where appropriate, that they be the
basis for U.S. standards. In addition, it
is the policy of the Administration to
remove or diminish, to the extent
feasible, barriers to international trade,
including both barriers affecting the
export of American goods and services
to foreign countries and barriers
affecting the import of foreign goods and
services into the U.S. In accordance
with the above statute and policy, OST
has assessed the potential effect of this
rulemaking and has determined that it
will have only a domestic impact and
therefore no effect on any tradesensitive activity.
H. Energy Impact
The energy impact of the final rule
has been assessed in accordance with
the Energy Policy and Conservation Act
(EPCA), Pub. L. 94–163 as amended (42
U.S.C. 6362). We have determined that
the final rule is not a major regulatory
action under the provisions of the
EPCA.
List of Subjects
14 CFR Part 119
Administrative practice and
procedure, Air carriers, Aircraft,
Aviation safety, Charter flights,
Reporting and recordkeeping
requirements.
14 CFR Part 234
Air carriers, Consumer protection,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, 14 CFR chapters I and II are
amended as follows:
I
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15:21 Feb 11, 2005
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Chapter I—Federal Aviation
Administration, Department of
Transportation
PART 119—CERTIFICATION: AIR
CARRIERS AND COMMERCIAL
OPERATORS
1. The authority citation for Part 119 is
revised to read as follows:
I
Authority: 49 U.S.C. 106(g), 1153, 40101,
40102, 40103, 40113, 44105, 44106, 44111,
44701–44717, 44722, 44901, 44903, 44904,
44906, 44912, 44914, 44936, 44938, 46103,
46105.
§ 119.72
I
[Removed]
2. Section 119.72 is removed.
Chapter II—Office of the Secretary,
Department of Transportation
PART 234—AIRLINE SERVICE
QUALITY PERFORMANCE REPORTS
3. The authority citation for Part 234 is
revised to read as follows:
I
Authority: 49 U.S.C. 329 and chapters 401
and 417.
4. Section 234.13 is added to read as
follows:
I
§ 234.13 Reports by air carriers on
incidents involving animals during air
transport.
(a) Any air carrier that provides
scheduled passenger air transportation
shall, within 15 days of the end of the
month to which the information applies,
submit to the United States Department
of Transportation’s Aviation Consumer
Protection Division a report on any
incidents involving the loss, injury, or
death of an animal during air transport
provided by the air carrier.
(b) The report shall be made in the
form and manner set forth in reporting
directives issued by the Deputy General
Counsel for the U.S. Department of
Transportation and shall contain the
following information:
(1) Carrier and flight number;
(2) Date and time of the incident;
(3) Description of the animal,
including name, if applicable;
(4) Identification of the owner(s) and/
or guardian of the animal;
(5) Narrative description of the
incident;
(6) Narrative description of the cause
of the incident;
(7) Narrative description of any
corrective action taken in response to
the incident; and
(8) Name, title, address, and
telephone number of the individual
filing the report on behalf of the air
carrier.
(c) For purposes of this section:
(1) The air transport of an animal
includes the entire period during which
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an animal is in the custody of an air
carrier, from check-in of the animal
prior to departure until the animal is
returned to the owner or guardian of the
animal at the final destination of the
animal; and
(2) Animal means any warm or cold
blooded animal which, at the time of
transportation, is being kept as a pet in
a family household in the United States.
Issued in Washington, DC, on February 4,
2005.
Norman Y. Mineta,
Secretary.
[FR Doc. 05–2755 Filed 2–11–05; 8:45 am]
BILLING CODE 4910–62–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 2003F–0535]
Secondary Direct Food Additives
Permitted in Food for Human
Consumption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
food additive regulations to permit the
manufacture of chlorine dioxide by
electrolysis of an aqueous solution of
sodium chlorite. This action is in
response to a petition filed by Vulcan
Chemicals.
DATES: This rule is effective February
14, 2005. Submit written or electronic
objections and requests for a hearing by
March 16, 2005. See section VI of this
document for information on the filing
of objections. The Director of the Office
of the Federal Register approves the
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51 of certain publications in
§ 173.300 (21 CFR 173.300) as of
February 14, 2005.
ADDRESSES: You may submit written
objections and requests for a hearing,
identified by Docket No. 2003F–0535,
by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov.
Include Docket No. 2003F–0535 in the
subject line of your e-mail message.
E:\FR\FM\14FER1.SGM
14FER1
Federal Register / Vol. 70, No. 29 / Monday, February 14, 2005 / Rules and Regulations
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD-ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
objections received will be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
C. DeLeo, Center for Food Safety and
Applied Nutrition (HFS–265), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1302.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal
Register of December 1, 2003 (68 FR
67195), FDA announced that a food
additive petition (FAP 4A4751) had
been filed by Vulcan Chemicals, P.O.
Box 385015, Birmingham, AL 35238–
5015. The petition proposed to amend
the food additive regulations in
§ 173.300 Chlorine dioxide (21 CFR
173.300) to provide for an additional
method for producing the additive,
specifically, treating an aqueous
solution of sodium chlorite by
electrolysis.
In the notice of filing, the agency
announced that it was placing the
environmental assessment on display at
the Division of Dockets Management for
public review and comment. FDA did
not receive any comments addressing
the potential environmental effects of
the proposed change to the regulation.
As discussed below, the agency has
determined that this action will not
have a significant impact on the human
environment and that an environmental
impact statement is not required.
II. Conclusion
FDA has evaluated data in the
petition and other relevant material.
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15:21 Feb 11, 2005
Jkt 205001
Based on this information, the agency
concludes that chlorine dioxide
generated by electrolysis of an aqueous
solution of sodium chlorite is equivalent
to the chlorine dioxide generated by the
currently-approved methods as
described in § 173.300 (Ref. 1). In
addition, the chlorine dioxide generated
by the electrolytic process will have the
same intended technical effect and use
as the chlorine dioxide produced by the
currently-approved methods.
Consequently, there will be no change
in the exposure to chlorine dioxide from
the petitioned use. Therefore, FDA
concludes that § 173.300 should be
amended as set forth below.
Based on a request by the petitioner,
the FDA is also updating § 173.300 by
citing the 20th edition of the method
that is incorporated by reference rather
than the 18th edition. Section 173.300
currently incorporates by reference
Method 4500–ClO2 E in the ‘‘Standard
Methods for the Examination of Water
and Wastewater,’’ 18th ed., 1992. The
agency compared the 18th and 20th
editions of this method and found them
to be identical. Therefore, the agency is
making this requested editorial change.
III. Public Disclosure
In accordance with § 171.1(h) (21 CFR
171.1(h)), the petition and the
documents that FDA considered and
relied upon in reaching its decision to
approve the petition are available for
inspection at the Center for Food Safety
and Applied Nutrition by appointment
with the information contact person
listed in this document. As provided in
§ 171.1(h) the agency will delete from
the documents any materials that are
not available for public disclosure
before making the documents available
for inspection.
IV. Environmental Impact
The agency has carefully considered
the potential environmental effects of
this action. FDA has concluded that the
action will not have a significant impact
on the human environment, and that an
environmental impact statement is not
required. The agency’s finding of no
significant impact and the evidence
supporting that finding, contained in an
environmental assessment, may be seen
in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday.
7395
VI. Objection and Hearing Requests
Any person who will be adversely
affected by this regulation may file with
the Division of Dockets Management
(see ADDRESSES) written objections by
(see DATES). Each objection shall be
separately numbered, and each
numbered objection shall specify with
particularity the provisions of the
regulation to which objection is made
and the grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection. Three copies of all documents
are to be submitted and are to be
identified with the docket number
found in brackets in the heading of this
document. Any objections received in
response to the regulation may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
VII. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Memorandum from H. Lee, FDA
Division of Petition Review, Chemistry
Review Group, to P. DeLeo, FDA, Division of
Petition Review, Regulatory Group I, March
17, 2004.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by
reference.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to the
Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 173 is
amended as follows:
I
V. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
PART 173—SECONDARY DIRECT
FOOD ADDITIVES PERMITTED IN
FOOD FOR HUMAN CONSUMPTION
I
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1. The authority citation for 21 CFR
part 173 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
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14FER1
7396
Federal Register / Vol. 70, No. 29 / Monday, February 14, 2005 / Rules and Regulations
2. Section 173.300 is amended by
revising paragraphs (a) and (b) to read as
follows:
I
§ 173.300
Chlorine dioxide.
*
*
*
*
*
(a)(1) The additive is generated by one
of the following methods:
(i) Treating an aqueous solution of
sodium chlorite with either chlorine gas
or a mixture of sodium hypochlorite and
hydrochloric acid.
(ii) Treating an aqueous solution of
sodium chlorate with hydrogen
peroxide in the presence of sulfuric
acid.
(iii) Treating an aqueous solution of
sodium chlorite by electrolysis.
(2) The generator effluent contains at
least 90 percent (by weight) of chlorine
dioxide with respect to all chlorine
species as determined by Method 4500–
ClO2 E in the ‘‘Standard Methods for the
Examination of Water and Wastewater,’’
20th ed., 1998, or an equivalent method.
Method 4500–ClO2 E (‘‘Amperometric
Method II’’) is incorporated by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
from the Center for Food Safety and
Applied Nutrition (HFS–200), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or the
American Public Health Association,
800 I St. NW., Washington, DC 20001–
3750. You may inspect a copy at the
Center for Food Safety and Applied
Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD, or at the
National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
(b)(1) The additive may be used as an
antimicrobial agent in water used in
poultry processing in an amount not to
exceed 3 parts per million (ppm)
residual chlorine dioxide as determined
by Method 4500–ClO2 E, referenced in
paragraph (a)(2) of this section, or an
equivalent method.
(2) The additive may be used as an
antimicrobial agent in water used to
wash fruits and vegetables that are not
raw agricultural commodities in an
amount not to exceed 3 ppm residual
chlorine dioxide as determined by
Method 4500–ClO2 E, referenced in
paragraph (a)(2) of this section, or an
equivalent method. Treatment of the
fruits and vegetables with chlorine
dioxide shall be followed by a potable
water rinse or by blanching, cooking, or
canning.
VerDate jul<14>2003
15:21 Feb 11, 2005
Jkt 205001
Dated: January 28, 2005.
Leslye M. Fraser,
Director, Office of Regulations and Policy,
Center for Food Safety and Applied Nutrition.
[FR Doc. 05–2808 Filed 2–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 301 and 602
[TD 9178]
RIN 1545–BB15
Testimony or Production of Records in
a Court or Other Proceeding
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation.
AGENCY:
SUMMARY: This document contains final
regulations replacing the existing
regulation that establishes the
procedures to be followed by IRS
officers and employees upon receipt of
a request or demand for disclosure of
IRS records or information. The purpose
of the final regulations is to provide
specific instructions and to clarify the
circumstances under which more
specific procedures take precedence.
The final regulations extend the
application of the regulation to former
IRS officers and employees as well as to
persons who are or were under contract
to the IRS. The final regulations affect
current and former IRS officers,
employees and contractors, and persons
who make requests or demands for
disclosure.
Effective Date: These regulations
are effective February 14, 2005.
Applicability Date: For dates of
applicability, see § 301.9000–7.
FOR FURTHER INFORMATION CONTACT:
Scott E. Powers, (202) 622–4580 (not a
toll free number).
SUPPLEMENTARY INFORMATION:
DATES:
Paperwork Reduction Act
The collections of information
contained in these final regulations have
been submitted to the Office of
Management and Budget for review in
accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
1850.
The collections of information are in
§ 301.9000–5. This information is
required to enable the IRS to provide
authorizing officials with a better
informed basis upon which to
determine whether to grant, deny, or
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Fmt 4700
Sfmt 4700
limit testimony or the disclosure of IRS
records or information so as to conserve
agency resources.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
number assigned by the Office of
Management and Budget.
The burden reflected in the notice of
proposed rulemaking (REG–140930–02)
relating to the procedures for IRS
officers and employees to follow upon
receipt of a request or demand for
disclosure of IRS records or information
was published in the Federal Register
(68 FR 40850). Comments concerning
the accuracy of this burden estimate and
suggestions for reducing this burden
should be sent to the Internal Revenue
Service, Attn: IRS Reports Clearance
Officer, SE:W:CAR:MP:T:T:SP,
Washington, DC 20224, and to the
Office of Management and Budget, Attn:
Desk Officer for the Department of the
Treasury, Office of Information and
Regulatory Affairs, Washington, DC
20503.
Books or records relating to a
collection of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
are confidential, as required by section
6103 of the Internal Revenue Code.
Background
This document contains amendments
to 26 CFR part 301 under 5 U.S.C. 301
and 26 CFR part 602. On July 9, 2003,
a notice of proposed rulemaking (REG–
140930–02) relating to the procedures
for IRS officers and employees to follow
upon receipt of a request or demand for
disclosure of IRS records or information
was published in the Federal Register
(68 FR 40850). No comments were
received from the public in response to
the notice of proposed rulemaking. No
public hearing was requested or held.
The proposed regulations are adopted as
amended by this Treasury decision.
With the exception of changes that are
grammatical in nature, the revisions are
discussed below.
Summary of Comments and
Explanation of Revisions
The regulations have been clarified by
the addition of an example illustrating
a situation in which testimony
authorization is required. In addition,
text and examples have been added to
illustrate that even though testimony
authorization may not be required, any
disclosure of IRS records and
information must be proper under the
applicable substantive law. For
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14FER1
]]>Agencies
[Federal Register Volume 70, Number 29 (Monday, February 14, 2005)]
[Rules and Regulations]
[Pages 7394-7396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2808]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 2003F-0535]
Secondary Direct Food Additives Permitted in Food for Human
Consumption
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to permit the manufacture of chlorine dioxide by
electrolysis of an aqueous solution of sodium chlorite. This action is
in response to a petition filed by Vulcan Chemicals.
DATES: This rule is effective February 14, 2005. Submit written or
electronic objections and requests for a hearing by March 16, 2005. See
section VI of this document for information on the filing of
objections. The Director of the Office of the Federal Register approves
the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51 of certain publications in Sec. 173.300 (21 CFR 173.300)
as of February 14, 2005.
ADDRESSES: You may submit written objections and requests for a
hearing, identified by Docket No. 2003F-0535, by any of the following
methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F-
0535 in the subject line of your e-mail message.
[[Page 7395]]
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All objections received will be
posted without change to https://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of December 1, 2003
(68 FR 67195), FDA announced that a food additive petition (FAP 4A4751)
had been filed by Vulcan Chemicals, P.O. Box 385015, Birmingham, AL
35238-5015. The petition proposed to amend the food additive
regulations in Sec. 173.300 Chlorine dioxide (21 CFR 173.300) to
provide for an additional method for producing the additive,
specifically, treating an aqueous solution of sodium chlorite by
electrolysis.
In the notice of filing, the agency announced that it was placing
the environmental assessment on display at the Division of Dockets
Management for public review and comment. FDA did not receive any
comments addressing the potential environmental effects of the proposed
change to the regulation. As discussed below, the agency has determined
that this action will not have a significant impact on the human
environment and that an environmental impact statement is not required.
II. Conclusion
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that chlorine dioxide
generated by electrolysis of an aqueous solution of sodium chlorite is
equivalent to the chlorine dioxide generated by the currently-approved
methods as described in Sec. 173.300 (Ref. 1). In addition, the
chlorine dioxide generated by the electrolytic process will have the
same intended technical effect and use as the chlorine dioxide produced
by the currently-approved methods. Consequently, there will be no
change in the exposure to chlorine dioxide from the petitioned use.
Therefore, FDA concludes that Sec. 173.300 should be amended as set
forth below.
Based on a request by the petitioner, the FDA is also updating
Sec. 173.300 by citing the 20th edition of the method that is
incorporated by reference rather than the 18th edition. Section 173.300
currently incorporates by reference Method 4500-ClO2 E in
the ``Standard Methods for the Examination of Water and Wastewater,''
18th ed., 1992. The agency compared the 18th and 20th editions of this
method and found them to be identical. Therefore, the agency is making
this requested editorial change.
III. Public Disclosure
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed in this document. As provided in
Sec. 171.1(h) the agency will delete from the documents any materials
that are not available for public disclosure before making the
documents available for inspection.
IV. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Division
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
V. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VI. Objection and Hearing Requests
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) written
objections by (see DATES). Each objection shall be separately numbered,
and each numbered objection shall specify with particularity the
provisions of the regulation to which objection is made and the grounds
for the objection. Each numbered objection on which a hearing is
requested shall specifically so state. Failure to request a hearing for
any particular objection shall constitute a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested shall include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection shall
constitute a waiver of the right to a hearing on the objection. Three
copies of all documents are to be submitted and are to be identified
with the docket number found in brackets in the heading of this
document. Any objections received in response to the regulation may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VII. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from H. Lee, FDA Division of Petition Review,
Chemistry Review Group, to P. DeLeo, FDA, Division of Petition
Review, Regulatory Group I, March 17, 2004.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by reference.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
[[Page 7396]]
0
2. Section 173.300 is amended by revising paragraphs (a) and (b) to
read as follows:
Sec. 173.300 Chlorine dioxide.
* * * * *
(a)(1) The additive is generated by one of the following methods:
(i) Treating an aqueous solution of sodium chlorite with either
chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid.
(ii) Treating an aqueous solution of sodium chlorate with hydrogen
peroxide in the presence of sulfuric acid.
(iii) Treating an aqueous solution of sodium chlorite by
electrolysis.
(2) The generator effluent contains at least 90 percent (by weight)
of chlorine dioxide with respect to all chlorine species as determined
by Method 4500-ClO2 E in the ``Standard Methods for the
Examination of Water and Wastewater,'' 20th ed., 1998, or an equivalent
method. Method 4500-ClO2 E (``Amperometric Method II'') is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain a copy from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or the American Public Health
Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect
a copy at the Center for Food Safety and Applied Nutrition's Library,
5100 Paint Branch Pkwy., College Park, MD, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: https://
www.archives.gov/federal_register/code_of_federal_regulations/ibr_
locations.html.
(b)(1) The additive may be used as an antimicrobial agent in water
used in poultry processing in an amount not to exceed 3 parts per
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a)(2) of this section, or
an equivalent method.
(2) The additive may be used as an antimicrobial agent in water
used to wash fruits and vegetables that are not raw agricultural
commodities in an amount not to exceed 3 ppm residual chlorine dioxide
as determined by Method 4500-ClO2 E, referenced in paragraph
(a)(2) of this section, or an equivalent method. Treatment of the
fruits and vegetables with chlorine dioxide shall be followed by a
potable water rinse or by blanching, cooking, or canning.
Dated: January 28, 2005.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. 05-2808 Filed 2-11-05; 8:45 am]
BILLING CODE 4160-01-S
